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Biomedical subjects

G Falkson

Publications and source records attributed to G Falkson.

At least 37 records · Page 2Linked to original sources
PubMed1995

Hepatocellular carcinoma. An ECOG randomized phase II study of beta-interferon and menogaril.

This study was undertaken to investigate the response rate, time to treatment failure and survival time of patients with hepatocellular cancer (HCC) treated with beta-interferon or menogaril. Sixty-nine patients with histologically confirmed, advanced, measurable hepatocellular carcinoma were randomized to receive beta-interferon or menogaril. Eligibility criteria included an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2, or 3, as well as adequate kidney and liver function and hematologic reserve. The number of patients with lethal, life-threatening, and severe toxicities on beta-interferon were 1, 3, and 12 and on menogaril 2, 5, and 10, respectively. No objective responses were documented among the 61 patients who had HCC, histologically reviewed and confirmed. The time to treatment failure was 6.7 weeks on beta-interferon and 8.6 weeks on menogaril. The median survival time was 11.1 weeks on beta-interferon and 23.1 weeks on menogaril (South African patients 10.1 weeks). The difference is not significant. Poor prognostic factors were jaundice, age, and associated hepatitis. After controlling for other covariates, beta-interferon appears to increase the relative risk of dying by 2.7. This trial reconfirms the importance, previously reported by ECOG of jaundice and age in the prognosis of patients with HCC. It shows that further trials with neither beta-interferon nor menogaril are warranted.

Aged↗
PubMed1994

FIVB plus GM-CSF in metastatic colorectal cancer.

The response rate of patients with metastatic colorectal cancer to the 4-drug combination [5-Fluorouracil (5-FU), dacarbazine, vincristine and bis-chloronitrosourea given 5 weekly (FIVB)] was better than the response rate to 5-FU. The dose limiting toxicity of the FIVB was myelosuppression. The present study investigates the effect of FIVB given with GM-CSF so that drug cycles could be given every 4 weeks. Thirty-five ambulatory patients with measurable metastatic colorectal cancer were treated with FIVB plus GM-CSF 4 weekly. All patients were evaluable for toxicity. Among the 163 cycles given only 4 were delayed because of leucopenia and 8 cycles were delayed because of gastrointestinal (GI) toxicity. A 50% dose reduction was given to 10 patients who had Grade 2 and 3 GI toxicity. Four of the 35 patients developed thromboembolic complications, 2 of which were lethal. Two patients were not evaluable for response as they were removed from study early because of toxicity. There were 2 complete responses and 6 partial responses. The median time to treatment failure was 3.8 months and median survival time 9.9 months. The addition of GM-CSF to FIVB decreased the expected leucopenia allowing drug treatment to be given 4 weekly to most patients. GI toxicity was dose limiting. Despite the increased dose intensity that could be delivered (to two thirds of patients), response rates were not definitely increased, no survival benefit was seen and important thromboembolic complications occurred.

Adult↗
PubMed1994

Phase II trial of fotemustine in patients with metastatic malignant melanoma.

Fotemustine is a novel chloroethylnitrosourea, that readily penetrates the blood brain barrier. Preliminary French studies reported encouraging results with fotemustine in patients with cerebral metastases of malignant melanoma. Thirty-one patients with histologically confirmed metastatic malignant melanoma were entered on a phase II trial. The treatment regimen consisted of fotemustine, administered intravenously as a rapid infusion, at a dose of 100 mg/m2 on day 1, 8 and 15 every 4 to 5 weeks. Objective response (CR + PR) was documented in 3 patients. Median time to treatment failure (TTF) was 44 days and median survival was 164 days. Life threatening toxicity did not occur; hematological toxicity and nausea and vomiting were the most common toxicities. Despite a somewhat disappointing response rate, objective responses were documented in patients with cerebral metastases. Since no other chemotherapeutic agent has shown therapeutic efficacy in cerebral metastases from malignant melanoma fotemustine therefore warrants further study.

Adult↗
PubMed1994

Reinduction with the same cytostatic treatment in patients with metastatic breast cancer: an Eastern Cooperative Oncology Group study.

PURPOSE: To investigate the therapeutic value of reinduction with the same cytostatic treatment that had been used in induction treatment for women with metastatic breast cancer. MATERIALS AND METHODS: One hundred six women with metastatic breast cancer were given dibromodulcitol (mitolactol), doxorubicin, vincristine, tamoxifen, and fluoxymesterone (DAVTH) for 6 months of induction treatment, then randomized to receive one of two chemotherapy regimens if they had obtained an induction partial response (PR) or no change (NC), or to receive observation versus chemotherapy if they had obtained an induction complete response (CR). Patients were then retreated with DAVTH reinduction after relapse. RESULTS: Seventy-four patients were eligible or had minor reasons for ineligibility. Severe or life-threatening toxicity was documented in 46%, and lethal toxicity in 4%. Eighteen percent had a response on reinduction (zero of 16 induction nonresponders, 15% induction PR, 44% induction CR). The median time to treatment failure (TTF) from reinduction was 3 months, and the median survival duration from reinduction was 14 months. In a logistic model, factors associated with more reinduction responses were observation after induction CR (P = .002) and age greater than 55 years (P = .04). Time since induction was not significant. CONCLUSION: Reinduction of response after treatment failure remains a therapeutic problem. The need for better salvage treatment underlines the importance of developing new regimens.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1994

Efficacy and safety profile of gemcitabine in non-small-cell lung cancer: a phase II study.

PURPOSE: The aim of this study was to evaluate the efficacy and toxicity of gemcitabine at higher doses than had been used previously in patients with non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Eighty-four patients (65 men, 19 women; age range, 35 to 75 years; mean age, 59 years) with locally advanced or metastatic pathologically documented NSCLC were enrolled. Patients had bidimensionally measurable disease, as defined by computed tomographic (CT) scan or chest x-ray. A total of 28.6% had previously been surgically treated, while 9.5% had received radiotherapy. Fifty-three patients commenced at a dose of 1,000 mg/m2, and 31 at a dose of 1,250 mg/m2. Patients were to receive two dose escalations of 25%, provided that overall toxicity was no worse than World Health Organization (WHO) grade 1 or WHO grade 0 for platelets. Responding patients were reviewed and validated by a blinded oncology review board (ORB) of experts not involved with the study. Of the original 84 patients enrolled, 76 were assessable. RESULTS: The overall response rate was 20% (95% confidence interval [CI], 11.6% to 30.8%). There were two complete responses (3%) and 13 partial responses (17%). Hematologic toxicity was negligible. WHO grade 3 WBC toxicity occurred in 0.9% of doses and WHO grade 4 in 0.1%. WHO grade 3 and 4 thrombocytopenia occurred in 0.1% and 0.1% of all doses, respectively. Nonhematologic toxicity was minor and easily controlled. Common side effects included peripheral edema, asthenia, and transient malaise. CONCLUSION: The single-agent efficacy of gemcitabine is equivalent to other agents commonly used to treat NSCLC. Gemcitabine has an unusually mild side effect profile for such an active agent. The nausea and vomiting experienced with gemcitabine are mild and generally well controlled with standard antiemetics; 5-HT3 receptor antagonists are typically not required. The use of gemcitabine does not cause significant alopecia, and hematologic toxicity is modest and unlikely to require hospitalization. Gemcitabine may have a role as monotherapy in patients with inoperable NSCLC.

Adult↗
PubMed1993

Repeated use of granisetron in patients receiving cytostatic agents.

BACKGROUND: Granisetron was shown to be a safe and effective antiemetic agent when given with initial cytostatic therapy. This study was undertaken to investigate the efficacy and safety of the continued use of granisetron. METHODS: Ninety-one patients were given 438 cycles of granisetron during subsequent courses of cytostatic treatment. In 56 patients, 40 micrograms/kg i.v. was given in 159 cycles, and in 42 patients, 3 mg i.v. was given in 279 cycles. In patients having breakthrough symptoms, as many as two rescue doses were given to re-establish control. RESULTS: Overall objective control of nausea and vomiting was observed in 88.6% of the 40 micrograms/kg-cycles and in 90.32% of the 3-mg cycles. In the 438 cycles given, complete control was achieved in 105 of 159 (66%) of the 40-micrograms/kg cycles and in 217 of 279 (77.78%) of the 3-mg cycles. Thirty-three patients received 97 cycles of cisplatin-based regimens. The objective control rate was 82.47% (80 of 97 cycles) in these patients. The control rate in patients receiving regimens not containing cisplatin was 94.4% (322 of 341 cycles). Rescue doses improved or resolved symptoms in 53 of 61 (86.9%) cycles. No statistically significant difference in nausea and vomiting control was seen between men and women or between the different age groups. The only toxicities encountered were headache in 14 of 438 (3.2%) cycles and mild constipation in 8 of 438 (1.8%) cycles. CONCLUSION: Granisetron is safe and well tolerated, maintains its antiemetic efficacy after repeated cycles of therapy, and is effective as an interventional treatment for nausea and vomiting.

Adult↗
PubMed1993

Survival determinants in patients with advanced ovarian cancer.

An analysis was performed on 127 consecutive women with advanced measurable ovarian cancer to evaluate factors predicting for survival. All patients received cis-platinum-based chemotherapy as treatment for stage IIIB to stage IV disease. Eighteen clinical, radiological, and biochemical parameters were subjected to univariate and multivariate analyses. Recursive partitioning and amalgamation (RPA) was used to define prognostic subsets with different survival potentials. In the univariate analysis, factors that predicted for survival were weight loss, histology, stage, number of metastases, presence of ascites, size of the residual tumor, and rate of tumor response. When these significant variables were included in a Cox model, advanced stage of disease, histology other than adenoserous carcinoma, the presence of tumor bulk, and a slow rate of tumor response independently predicted a poorer survival. Using the three disease-related prognostic variables, a RPA model was derived and three groups were identified with median survival times of 76, 28, and 21 months, respectively (P = 0.001). The best survival time of 76 months was seen in patients with stage III, nonbulky, adenoserous ovarian carcinoma. It is concluded that the rate of tumor response is important in predicting the outcome of patients with ovarian cancer. Furthermore, the interactions between prognostic factors are emphasized by the RPA model and a subgroup of patients with a projected 10-year survival of 50% is identified.

Analysis of Variance↗
PubMed1993

The value of radiotherapy or chemotherapy after intubation for advanced esophageal carcinoma--a prospective randomized trial.

After intubation for advanced, inoperable squamous carcinoma of the oesophagus, a prospectively controlled randomized trial was done to investigate the effect of radiotherapy (41 patients) or mono-chemotherapy (40 patients) or no further treatment (46 patients). Treatment had no significant effect on either palliation or survival (p < or = 0.7) and did not alter the natural history of the disease.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1993

Suramin in combination with mitomycin C in hormone-resistant prostate cancer. A phase II clinical study.

BACKGROUND: Hormone-resistant prostate cancer can respond to mitomycin C or to suramin. This trial was undertaken to investigate the value of mitomycin C given with low dose suramin. PATIENTS AND METHODS: Thirty-two patients with hormone-refractory prostate cancer were given suramin 350 mg/m2 daily for 5 days, followed by 350 mg/m2 weekly starting on day 14. Mitomycin C 12 mg/m2 was given every 5 weeks starting on day 14. RESULTS: Toxicity included maculo-papular skin rash in 8 patients, haematological toxicity in 16 (anaemia 13, leucopenia 11 and thrombocytopenia 9, bleeding 8), infection in 4 and fatigue in 11. Ten patients developed neurotoxicity, (temporary sensory peripheral neuropathy in 8, upper limb motor neuropathy in 1, and restless legs syndrome in 1) and 9 developed proteinuria. Other toxicities were mild nausea and vomiting, oedema, transient elevation of liver enzymes, stomatitis, upper gastrointestinal symptoms, and alopecia. During induction treatment the median trough suramin level was 140 micrograms/ml (range 100-273) and during maintenance treatment the median suramin level was 93 micrograms/ml. The median overall trough level was 93 micrograms/ml. There were one complete and 6 partial responses. Fifteen patients had disease stabilization. The median time to treatment failure was 103 days, and the median survival 209 days. CONCLUSION: The combination of suramin and mitomycin C has therapeutic activity, but causes significant toxicity in patients with hormone-resistant prostatic carcinoma.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1993

A randomized trial of mitomycin-C (M) versus mitomycin-C plus high-dose medroxyprogesterone acetate (MMPA) in the treatment of patients with advanced breast cancer.

Seventy-six women with previously treated breast cancer were randomized to receive mitomycin (M) or M plus high-dose oral medroxyprogesterone acetate (MMPA). Patients were balanced with respect to age, performance status, hormone receptor status, previous treatment, and number of metastatic sites. There were more patients with visceral metastases in the M arm of the study. Side effects were tolerable and not significantly different for the two regimens. No life-threatening toxicity occurred. Objective response was documented in 4 of 37 patients on M and 11 of 39 on MMPA. On M the median time to treatment failure (TTF) was 3 months, and median survival was 7.8 months. On MMPA the median TTF was 4.4 months, and median survival was 9.7 months. There was a tendency for higher response and longer TTF and survival on MMPA, but statistical significance was not reached (p = 0.09).

Adult↗
PubMed1993

Combined modality treatment of gastrointestinal cancer.

During the past year, little of finite value has been published to change the approach to combined treatment modalities for the patient with gastrointestinal cancer. The value of adding other modalities to surgery to improve the cure rate has been marginal. Neoadjuvant and adjuvant treatment appear to be making inroads into the treatment of esophagus cancer, and newer development of less toxic treatment offers promise for the future. In stomach cancer, combined modality treatment is only of value for patients with locally advanced disease. In the United States, adjuvant chemotherapy is accepted as being of value for patients with colon cancer, and adjuvant treatment with both radiotherapy and chemotherapy is considered to be best for patients with surgically treatable rectum cancer. Primary liver cancer continues to offer a challenge for combined modality treatment, but a call for prospective, randomized control trials seems to be in order.

Chemotherapy, Adjuvant↗
PubMed1993

Adjuvant tamoxifen versus placebo in elderly women with node-positive breast cancer: long-term follow-up and causes of death.

PURPOSE: This study analyzes the long-term results and causes of death in elderly women with node-positive breast cancer who participated in a double-blind adjuvant trial that compared tamoxifen with placebo to determine the benefit of 2 years of treatment. PATIENTS AND METHODS: One hundred eighty-one women 65 to 84 years old were given 20 mg of tamoxifen or placebo daily for 2 years after stratification by estrogen receptor status, tumor size, and degree of lymph node involvement. Approximately 30% of patients were older than 70 years and 20% were older than 75 years. Eighty-five percent were estrogen receptor-positive. Median follow-up was 10 years. RESULTS: Among the 168 eligible patients, there have been 98 recurrences (59 placebo v 39 tamoxifen), with reduced distant and bone-only first sites in patients treated with tamoxifen. Median time to failure was 4.4 years for placebo versus 7.4 years for tamoxifen (log-rank P = .001). A similar number of new nonbreast cancers occurred in each arm (seven placebo v six tamoxifen), but a reduced number of opposite-breast cancers (five placebo v one tamoxifen) was noted. Overall, there were 102 deaths (57 placebo v 45 tamoxifen). Median survivals were 8.0 years with placebo and 8.5 years with tamoxifen (log-rank P = .063); 50% of the tamoxifen patients and 33% of the placebo patients are still alive. Sixty-one percent of the deaths were reported to have been caused by breast cancer recurrence, 4% by other cancers, and 22% by the sequelae of non-cancer-related illness, with equal distributions for cardiovascular and cerebrovascular disease. There was no increase in the number of endometrial or other types of cancer, or thrombotic or orthopedic complications in this older group. CONCLUSION: Tamoxifen currently is the treatment of choice for elderly women with breast cancer. It extends the time to treatment failure by 3 years and reduces the number of recurrences, deaths, distant and bone-only first recurrences, and second breast cancers.

Aged↗
PubMed1992

Successful management of inferior vena cava and right atrial nephroblastoma tumor thrombus with preoperative chemotherapy.

Involvement of inferior vena cava (IVC) by tumor thrombus occurs in up to 10% of patients with nephroblastoma. Right atrial involvement by tumor thrombus is much less frequent. Four patients presenting with advanced nephroblastoma were diagnosed as having IVC involvement with tumor thrombus. Two of these patients had in addition thrombus extending up to the right atrium. All 4 patients were treated with preoperative chemotherapy (vincristine, actinomycin D, 4-epi-Adriamycin). Nephrectomy was subsequently performed without undue difficulty on all 4 patients. The intravascular tumor thrombus had completely cleared in all 4 patients and most of the primary renal tumor was necrotic. The results obtained with preoperative chemotherapy as given to these patients mediates strongly against difficult surgery being undertaken as primary treatment for such patients.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1992

Phase II clinical study of pirarubicin in hormone resistant prostate cancer.

Twenty one patients with hormone resistant prostate cancer were entered in a phase II study of pirarubicin 70 mg/m2, as a single intravenous injection given at 21 day intervals. All patients had leukopenia (9 severe or life threatening) and 2 died of septicemia. Thrombocytopenia occurred in 5 patients (one life threatening) and anemia in 12 patients. One partial response of 3 months duration was documented. Pirarubicin 70 mg/m2 given intravenously at 21 day intervals causes severe hematological toxicity and has minimal therapeutic activity in patients with hormone resistant prostate cancer.

Aged↗